Responsibilities:

- Establish and maintain document control process, including origin of internal or external, to ensure only valid and current version can be used

- Maintain all quality related records well controlled to ensure a good record practice is implemented through routine training and monitoring in on-line document system

- Support to monitor and follow up the CAPA status and support on internal audit program to ensure the system is consistently complying to applicable standards/regulations

-Responsible for quality system data collection and analysis to detect any abnormal trending or opportunity for improvement

- Responsible to support product registration per request

- Other responsibility defined in related company procedures or assigned by QARA Supervisor

Qualifications:

-Bachelor’s degree or above

-ISO13485:2016 Internal Auditor Certificate

-3-year above similar quality system management experience in Medical device or Pharmaceutical industry

-Solid understanding on ISO13485 and Familiar with GMP&GSP or other Medical Device related regulations

-Good CAPA management ability

-Good command of English and Mandarin

-Good knowledge with PC application

-On-line document control system experience

-Accountability, Learning Agile, “Can do” attitude, Teamwork Spirit

-Down to earth capability

-QARA team at both corporate and regional levels as well as the functional departments in Shanghai

The Sol-Millennium Group is dedicated to Building a Healthier Tomorrow and helping people live in a healthier world.  Our team members are committed to improve the safety and well-being of healthcare workers and their patients with the design and development of safety medical devices.      Sol-Millennium Group is a Global Healthcare Company providing innovative products and value added services through product development, manufacturing and distribution targeting safe injections and disposal of medical devices.  Our belief that the front line professionals are critical in the development process, we continually are in touch to share knowledge, ideas with concentration on the improved functionality of injection safety which is led by our experienced Research and Development team.  The Sol-Millennium culture focuses on continuous improvement, technological innovation and customer service.

http://www.sol-m.com